The TELE-SPACER study is a multicenter, noncommercial, physician-initiated, proof-of-concept, prospective, randomized, controlled, unblinded clinical trial and registry designed to compare two methods of treatment of patients with functional Atrio-Ventricular Block (AVB): the guidelines-recommended elective pacemaker (PM) therapy vs cardiovascular autonomic tests (CAT), electrophysiologic assessment (EPS) with referral to cardioneuroablation (CNA) and reevaluation of indications for PM therapy.
The main questions TELE-SPACER aims to answer are:
* Can the investigators successfully treat functional AVB without implantable device (PM)? * Can the investigators prove the feasibility and safety and demonstrate non-inferiority of CNA procedure in patients with functional AVB, avoiding long-term permanent pacing, its limitations, complications and costs ?
The TELE-SPACER trial will validate the European Society of Cardiology (ESC) recommendations (level C of evidence: expert opinion) for elective PM implantation and will introduce CNA as effective treatment in the functional AVB patient population.
Functional AVB - defined as a persistent or paroxysmal AVB with a positive results of atropine test
Written informed consent to participate in the study
Age 18-75
Symptomatic first degree AVB (above 300 msec). Class IIaC
Symptomatic Mobitz type I second degree AVB. Class IIaC
Implanted pacemaker/ICD/CRT
Sinus node dysfunction with indication for pacemaker implantation
Planned ablation of the atrioventricular junction
Severe prolonged bradycardia in advanced AVB requiring intravenous drugs and temporary pacing